510(k) K213254 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Axialis Ophthalmic Ultrasound System
| Applicant | Quantel Medical, Cournon D' Auvergne-Cedex, FR |
| Decision | Substantially Equivalent, Nov 15, 2021 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213254
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.